FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
138505–138528 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 26, 1987
BIOPRO FEMORAL HIP COMPONENT
K872535 · KWL
Biopro, Inc.
Orthopedic · 61d
Cleared Aug 26, 1987
INTERNATIONAL MODEL AT 8185 CUSTOM-IN-THE-EAR
K872647 · ESD
Int'L Hearing Aids, Inc.
Ear, Nose, Throat · 50d
Cleared Aug 26, 1987
BIOTROL-33 PLUS PATHOLOGIQUE ASSAYED CHEM. CONTROL
K872777 · JJY
Biotrol, USA, Inc.
Chemistry · 43d
Cleared Aug 26, 1987
BIOTROL-33 PLUS ASSAYED CHEMISTRY CONTROL SERUM
K872785 · JJY
Biotrol, USA, Inc.
Chemistry · 43d
Cleared Aug 26, 1987
OVONIC COATED SURGICAL SCISSORS
K873046 · LRW
Micrins, Ltd.
General & Plastic Surgery · 22d
Cleared Aug 25, 1987
ROTA-STAT
K864811 · LIQ
Intl. Diagnostic Laboratories, Ltd.
Microbiology · 259d
Cleared Aug 25, 1987
IFA TEST FOR ANTIBODIES TO BORRELIA BURGDORFERI
K871246 · LSR
Zeus Scientific, Inc.
Microbiology · 151d
Cleared Aug 25, 1987
PROTOFLUOR Z
K871499 · JKJ
Helena Laboratories
Toxicology · 131d
Cleared Aug 25, 1987
CODMAN FLEXIBLE ENDOSCOPE
K871978 · GCQ
Codman & Shurtleff, Inc.
Gastroenterology & Urology · 95d
Cleared Aug 25, 1987
MMG URO-SELF CATHETER
K871999 · GBM
Medical Marketing Group
Gastroenterology & Urology · 91d
Cleared Aug 25, 1987
5 MHZ TRANSDUCER
K872074 · JOP
Sonicaid, Inc.
Cardiovascular · 88d
Cleared Aug 25, 1987
INFANT FEEDING KIT/SET NASOGASTRIC FEEDING KIT
K872096 · KNT
Tri-State Hospital Supply Corp.
Gastroenterology & Urology · 85d
Cleared Aug 25, 1987
INFANT FEEDING TUBE
K872097 · KNT
Tri-State Hospital Supply Corp.
Gastroenterology & Urology · 85d
Cleared Aug 25, 1987
TANDEMR M-PAK LH IMMUNOENZYMETRIC ASSAY
K872131 · CEP
Hybritech, Inc.
Chemistry · 82d
Cleared Aug 25, 1987
MODIFIED INSTAFIL
K872446 · LHI
Instafil, Inc.
General Hospital · 63d
Cleared Aug 25, 1987
MULTIPLE NEEDLE, INJECTION, DISPOSABLE
K872566 · FMI
Cotran Corp.
General Hospital · 57d
Cleared Aug 25, 1987
ENDOCOAGULATOR(TM) MODEL 20 ARGON LASER FOR UROLO.
K872630 · LNK
Hgm, Inc.
Gastroenterology & Urology · 50d
Cleared Aug 25, 1987
NORFOLK NORPORT (TM) -SP (SKIN PARALLEL)
K872838 · LJT
Norfolk Medical Products, Inc.
General Hospital · 36d
Cleared Aug 25, 1987
CIBA CORNING 288 PH/BLOOD GAS SYSTEM
K872888 · JQY
Ciba Corning Diagnostics Corp.
Chemistry · 33d
Cleared Aug 25, 1987
MEDIUM 199 NO. M3274 W/HANKS' SALTS W.O/L-GLUTAMI.
K873090 · KIT
Sigma Chemical Co.
Pathology · 19d
Cleared Aug 25, 1987
AMES' MEDIUM NO. A1420 W/L-GLUTA. W.O/SOD. BICARB.
K873091 · KIT
Sigma Chemical Co.
Pathology · 19d
Cleared Aug 25, 1987
RPMI-1640 MEDIUM NO. R7755 AUTO-MOD(TM) W.O/L-GLU.
K873092 · KIT
Sigma Chemical Co.
Pathology · 19d
Cleared Aug 25, 1987
(MEM) EAGLE NO. M3024 W/EARLE'S SALTS
K873093 · KIT
Sigma Chemical Co.
Pathology · 19d
Cleared Aug 25, 1987
(MEM) EAGLE NO. M7399 W/EARLE'S SALTS
K873094 · KIT
Sigma Chemical Co.
Pathology · 19d